[Federal Register Volume 63, Number 29 (Thursday, February 12, 1998)]
[Notices]
[Pages 7173-7174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3504]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0327]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
March 16, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

Petition For Administrative Stay of Action--21 CFR 10.35--(OMB 
Control Number 0910-0194)--Reinstatement

     FDA regulations in 21 CFR 10.35, issued under the authority of 
section 701(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
371(a)), set forth the format and procedures by which an interested 
person may file a petition for an administrative stay of action.
     Respondents to this collection of information are interested 
persons who choose to file a petition for an administrative stay of 
action. Such a petition must: (1) Identify the decision involved; (2) 
state the action requested, including the length of time for which a 
stay is requested; and (3) include a statement of the factual and legal 
grounds on which the interested person relies in seeking the stay. The 
information provided in the petition is used by the agency to determine 
whether the requested stay should be granted.
     FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
10.35                                   7               1               7             100             700       
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  


[[Page 7174]]

    The burden estimate for this collection of information is based on 
FDA's experience with petitions for administrative stay of action over 
the past 3 years. Agency personnel responsible for processing the 
filing of petitions for administrative stays of action estimate that 
seven such petitions are received by the agency annually, with each 
requiring approximately 100 hours of preparation time.

    Dated: February 4, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-3504 Filed 2-11-98; 8:45 am]
BILLING CODE 4160-01-F